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Clinical trials for omalizumab (Xolair)

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44381   clinical trials with a EudraCT protocol, of which   7393   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    67 result(s) found for: omalizumab (Xolair). Displaying page 4 of 4.
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    EudraCT Number: 2019-002452-16 Sponsor Protocol Number: PTO95105013 Start Date*: 2020-02-04
    Sponsor Name:UMC Utrecht
    Full Title: Inhibition of Mast cell Activation in AtheroScleroTic lesions using an Anti-IgE antibody approach (MAST-trial)
    Medical condition: Atherosclerosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003538-28 Sponsor Protocol Number: CIGE025AIA05 Start Date*: 2016-02-16
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: A 1 Year, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Evaluation of Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omalizumab in Children (6 - < 12 Years)...
    Medical condition: Moderate-severe inadequately controlled Allergic Asthma
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-020841-29 Sponsor Protocol Number: ADAPT Start Date*: 2011-07-07
    Sponsor Name:King`s College London [...]
    1. King`s College London
    2. Guy`s & St Thomas` NHS Foundation Trust
    Full Title: The role of anti-IgE (omalizumab) in the management of severe recalcitrant paediatric atopic eczema
    Medical condition: Severe eczema in children
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004858 10003641 Atopic eczema LLT
    19.0 100000004858 10014189 Eczema allergic atopic LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-003627-30 Sponsor Protocol Number: 20170367744 Start Date*: 2018-06-27
    Sponsor Name:Odense Research Center for Anaphylaxis (ORCA)
    Full Title: Protection from food induced anaphylaxis by reducing serum level of specific IgE
    Medical condition: Food Allergy with Anaphylaxis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004870 10014315 Egg allergy LLT
    20.0 100000004870 10016709 Fish allergy LLT
    20.0 100000004870 10040539 Shellfish allergy LLT
    20.0 100000004870 10001745 Allergy to cow's milk LLT
    20.1 100000004870 10034202 Peanut allergy LLT
    20.0 100000004870 10027024 Meat allergy LLT
    20.0 100000004870 10011240 Cow's milk allergy LLT
    20.1 100000004870 10054957 Allergy to grains LLT
    20.1 100000004870 10054959 Allergy to nuts LLT
    20.0 100000004870 10064075 Seafood allergy LLT
    20.0 100000004870 10076438 Milk protein allergy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2008-001413-14 Sponsor Protocol Number: 205.416 Start Date*: 2008-08-20
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat ® inhaler (5 μg/day) over 48 ...
    Medical condition: Patients with severe persistent asthma who are still symptomatic despite being treated with high-dose inhaled corticosteroids and long-acting beta2-agonists. Additional asthma treatments are allowe...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10049106 Asthma chronic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-001414-25 Sponsor Protocol Number: 205.417 Start Date*: 2008-08-20
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat ® inhaler (5 μg/day) over 48 ...
    Medical condition: Patients with severe persistent asthma who are still symptomatic despite being treated with high-dose inhaled corticosteroids and long-acting beta2-agonists. Additional asthma treatments are allowe...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10049106 Asthma chronic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-014582-51 Sponsor Protocol Number: MO-90020714 Start Date*: 2010-03-26
    Sponsor Name:Faculty of Medicine, Technische Universität München
    Full Title: Pilot study - sequential combination therapy using selective immunoglobulin apheresis and omalizumab in patients with severe atopic dermatitis and elevated total IgE levels
    Medical condition: Patients with severe Atopic dermatitis and total IgE-level > 700 IU/ml (potentially associated with bronchial asthma and/or allergic rhinitis)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10002198 Anaphylactic reaction LLT
    12.0 10040400 Serum sickness LLT
    12.0 10043554 Thrombocytopenia LLT
    12.0 10019211 Headache LLT
    12.0 10028810 Nasopharyngitis LLT
    12.0 10040753 Sinusitis LLT
    12.0 10022000 Influenza LLT
    12.0 10006451 Bronchitis LLT
    12.0 10017888 Gastroenteritis LLT
    12.0 10034835 Pharyngitis LLT
    12.0 10047461 Viral infection LLT
    12.0 10034844 Pharyngolaryngeal pain LLT
    12.0 10011224 Cough LLT
    12.0 10039083 Rhinitis LLT
    12.0 10028735 Nasal congestion LLT
    12.0 10039085 Rhinitis allergic LLT
    12.0 10012727 Diarrhea LLT
    12.0 10028813 Nausea LLT
    12.0 10013946 Dyspepsia LLT
    12.0 10003988 Back pain LLT
    12.0 10003239 Arthralgia LLT
    12.0 10028411 Myalgia LLT
    12.0 10033425 Pain in extremity LLT
    12.0 10041014 Sleepiness LLT
    12.0 10046735 Urticaria LLT
    12.0 10015587 Exanthema LLT
    12.0 10037087 Pruritus LLT
    12.0 10012485 Dermatitis photosensitive LLT
    12.0 10000357 Accelerated hair loss LLT
    12.0 10033775 Paraesthesia LLT
    12.0 10042772 Syncope LLT
    12.0 10064973 Allergic bronchospasm LLT
    12.0 10001736 Allergic vasculitis LLT
    12.0 10053354 Blood pressure orthostatic abnormal LLT
    12.0 10063927 Orthostatic intolerance LLT
    12.0 10000188 Abnormal weight gain LLT
    12.0 10030095 Oedema PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
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    Query did not match any studies.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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